660-2005/01 – Assessment of health technologies (HZP)

Gurantor departmentCentre for Advanced Innovation TechnologiesCredits6
Subject guarantorIng. Lukáš Režný, Ph.D.Subject version guarantorIng. Lukáš Režný, Ph.D.
Study levelundergraduate or graduateRequirementCompulsory
Year1Semestersummer
Study languageCzech
Year of introduction2024/2025Year of cancellation
Intended for the facultiesFMTIntended for study typesBachelor
Instruction secured by
LoginNameTuitorTeacher giving lectures
PET497 Ing. Lukáš Peter, Ph.D.
REZ0135 Ing. Lukáš Režný, Ph.D.
Extent of instruction for forms of study
Form of studyWay of compl.Extent
Full-time Credit and Examination 2+1

Subject aims expressed by acquired skills and competences

The aim of the course is to provide students with knowledge and skills related to health technology assessment (HTA) as a systematic assessment of the properties, effects and impacts of health technology on the health of individuals and populations. HTA includes an assessment of the medical, economic, social, and ethical implications of a technology that informs decision-making not only by health care providers and patients, but also in its design, development, and use.

Teaching methods

Lectures
Seminars
Project work

Summary

Health technology assessment (HTA) is a multidisciplinary process that evaluates the medical, social, ethical, and economic implications of using a health technology, such as a medical device. In the course, students will learn to analyze and interpret data and metadata of medical devices from the perspective of: - Clinical effectiveness: How well does the product work in practice? What are its benefits and risks? Are there any alternative technologies that could achieve similar results? - Safety: What are the potential adverse events associated with the use of the medical device? What measures are in place to mitigate these risks? - Economic considerations: What is the cost-effectiveness of using the medical device? How does its price compare to alternative technologies? - Ethical and social aspects: What are the ethical and social consequences of using a medical device? What are the implications for patient privacy, data security and confidentiality? - Regulatory aspects: What are the regulatory requirements for the medical device? Is it approved for use by the relevant regulatory authorities? These individual aspects can optimize the selection of suitable technologies and materials, structural and ergonomic solutions even before the actual production of the medical device. HTA is a process that is an integral part of the design of a medical device. As part of the course, students work on an individual semester project.

Compulsory literature:

1. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) 2. Richard Edlin, Christopher McCabe, Claire Hulme, Peter Hall, Judy Wright. Cost Effectiveness Modelling for Health Technology Assessment: A Practical Course. Springer International Publishing Switzerland 2015, 208 pages, ISBN 978-3-319-15743-6. 3. Aswath Damodaran. The Little Book of Valuation: How to Value a Company, Pick a Stock and Profit ; 256 pages. ‎Wiley; 1st edition (May 3, 2011). Presentation from lectures

Recommended literature:

1. Webster, A., & Wyatt, S. (2020). Health, technology and society. Springer Singapore.

Way of continuous check of knowledge in the course of semester

Credit - presentation of an individual semester project Oral exam

E-learning

Other requirements

No further student requirements are required

Prerequisities

Subject has no prerequisities.

Co-requisities

Subject has no co-requisities.

Subject syllabus:

1. Introduction to HTA: an overview of the HTA process, different types of HTA and the role of HTA in decision making. 2. Study designs for HTA: an overview of the different study designs used in HTA, such as randomized controlled trials, observational studies and systematic reviews. 3. Clinical effectiveness: how to evaluate the clinical effectiveness of health technologies, including issues related to study design, patient selection, and outcome measurement. 4. Economic evaluation: types of economic evaluations used in HTA, such as cost-effectiveness analysis, cost-benefit analysis, and cost-benefit analysis. 5. HTA in practice: case studies of HTA in practice, including examples of HTA reports and their impact on decision-making. 6. Ethical and social aspects: ethical and social implications of the use of health technologies, including issues related to patient autonomy, privacy and access to care. 7. Regulatory aspects: regulatory requirements for health technologies, including the role of regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 8. HTA and decision making: how HTA is used to inform health care providers, policy makers and other stakeholders in decision making. 9. Patient-centered HTA: how to incorporate patient preferences and values into the HTA process. 10. Health outcomes research: methods used to measure and evaluate health outcomes, including patient-reported outcomes, health-related quality of life, and health utility. 11. HTA in global health: how HTA is used in low- and middle-income countries to inform resource allocation and improve access to health care. 12. Real-world evidence and HTA: how real-world evidence, such as data from electronic health records or patient registries, can be used to inform HTA. 13. The impact of HTA on the design and development of medical devices: how design and development can be influenced by the results of HTA 14. Presentation of individual projects

Conditions for subject completion

Full-time form (validity from: 2024/2025 Winter semester)
Task nameType of taskMax. number of points
(act. for subtasks)
Min. number of pointsMax. počet pokusů
Credit and Examination Credit and Examination 100 (100) 51
        Credit Credit 40  21
        Examination Examination 60  31 3
Mandatory attendence participation: Minimum participation of 80% in exercises

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Conditions for subject completion and attendance at the exercises within ISP: Elaboration and presentation of an individual semester project

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Occurrence in study plans

Academic yearProgrammeBranch/spec.Spec.ZaměřeníFormStudy language Tut. centreYearWSType of duty
2024/2025 (B0788P270002) Innovation and design of medical devices LZP P Czech Ostrava 1 Compulsory study plan

Occurrence in special blocks

Block nameAcademic yearForm of studyStudy language YearWSType of blockBlock owner

Assessment of instruction

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